In September, Cordis announced that a patient in Newport Beach, California, was the first to enroll in the company’s surveillance study of its carotid artery stenting (CAS) system for treatment of patients with carotid artery disease at high-risk for adverse events from carotid endarterectomy.
“Through this surveillance study we seek to corroborate findings of the landmark SAPPHIRE study, the only randomized clinical trial conducted to validate the potential of carotid artery stent placement in high surgical-risk patients,” said Dr Subbarao Myla, Medical Director, Cardiovascular Research and Vascular Interventions, Hoag Memorial Hospital Presbyterian, Newport Beach. “We are proud to be the first center to enroll a patient in this study.”
The launch of this study follows the approvable letter that Cordis received in August from the US Food and Drug Administration (FDA) for the Cordis PRECISE Nitinol self-expanding stent, part of the Cordis carotid system. The FDA will review separately the second generation embolic protection device, the Cordis ANGIOGUARD XP emboli capture guidewire system, the second component of the Cordis carotid system, under a 510K process.
Cordis is currently working closely with the FDA to fulfill requirements for final marketing approval of Cordis PRECISE and Cordis ANGIOGUARD. The FDA granted permission to Cordis Endovascular to initiate a surveillance study that will provide ongoing data about the carotid stenting procedure. When fully implemented, the surveillance study will enroll 1,500 patients at 112 sites in the United States. These centers are being selected by the company based on criteria agreed upon by the FDA and will represent a cross section of physicians who will be performing the procedure.
CASES Physician training program launched
As part of the surveillance study, the FDA also granted permission to Cordis Endovascular to launch its comprehensive training program for physicians and other relevant healthcare professionals called CASES (Cordis Carotid Artery Stenting Education System). This training will include didactic review, case observations and simulation training, and hands-on experience at a one of the Regional Education Centers across the country.
“Cordis CASES was developed by multiple thought leaders in the industry and was reviewed by the FDA and the Center for Medicaid/Medicare Services (CMS),” said Dr Dennis Donohoe, Vice President, Clinical and Regulatory Affairs, Cordis Endovascular. “It is the most recent initiative in Cordis’ legacy of providing health professionals with ‘best-in-class’ education and training to ensure patient safety and medical proficiency in performing this breakthrough procedure.” In addition to clinical outcomes, the company says that the surveillance study will serve to validate the CASES program.